FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K Number: K032351
·
Decision Oct 21, 2003
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
32
Review Days
83
Basic Information
- Device Name
- THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
- K Number
- K032351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOHORIZONS IMPLANT SYSTEMS, INC.
- Date Received
- July 30, 2003
- Decision Date
- October 21, 2003
- Product Code
- DZE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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|---|---|---|---|
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| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | Sep 9, 2010 | Substantially Equivalent |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | Apr 2, 2010 | Substantially Equivalent |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | Nov 13, 2008 | Substantially Equivalent |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | Feb 15, 2008 | Substantially Equivalent |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | Feb 8, 2008 | Substantially Equivalent |